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InflaRx N.V. (IFRX)
NasdaqGS - NasdaqGS Real Time Price. Currency in USD
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Raymond James remains Strong Buy on this stock with a $15 PT (for the time being). They assigned only a 5% probability of success with the Covid drug and didn't figure materially into their recommendation or price objective. The reason we own this stock is for their other drugs in the pipeline that are way more promising.
Havnt been in this name since the pop last october,
as the ev turns negative I like the risk reward here.
grabbed some at 1.80
EMA approval soon
news update about the letter correction from the FDA...
03-2022-InflaRx Receives Corrected Advice Letter from FDA Related to Phase III Program for Vilobelimab in Hidradenitis Suppurativa
The final data from the Company’s Phase IIa open-label study with vilobelimab in patients with pyoderma gangrenosum (PG) will be presented at the 2022 American Academy of Dermatology Association (AAD) Annual Meeting, being held March 25-29 in Boston, MA USA.
It will come back to 4 again
Very confusing development with Vilo. I take it the FDA is not going to allow the draining tunnels as part of the assessment criteria after all as the company had hoped and planned for. It sounds more like the FDA wants a repeat of the SHINE protocol. The company, I would imagine, will try to lobby for the new endpoints that would include draining tunnels following this letter. However, even if the study has to use the original criteria they will have a distinct advantage over the SHINE protocol in that they will use the higher 1600mg dose and they will control for the use of other meds such as steroids and other anti-inflammatory drugs which negatively affected the SHINE study results in 2019. (CCXI had the same issues seeking approval in ANCA vasculitis.) Anyway, the first dosing was not to occur until q2 so it is months away so there is no big delay here if this can be quickly worked out. Hopefully, they can clarify the endpoints in a mutually satisfactory manner. Again, the study is not stopped, but merely they are awaiting more details and are disappointed at the late hour exclusion of the draining tunnels in the study criteria. That is how I read this. Any other comments?
@Toms where are you? We need some advice.... Do we sell or buy?
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wonder where is JeffereyK Cass and Rodney Phoenix at they all bought this @ $6
Finally in below $3
Yahoo Finance Insights
InflaRx is down 11.36% to 1.95
Yahoo Finance Insights
InflaRx reached an all time low at 1.77
Toms . I hope you are getting above the morning minimum wage to seat here all day long and bash the stock ….
Yahoo Finance Insights
InflaRx reached an all time low at 1.75
Good day fellas! is this a little pump and dump we are seeing or is the shorts getting out?
I just listened to the entire CS webcast. As a dermatologist my biggest take aways were the following.
1) The Shine trial in HS had issues with placebo response, too low dosing, and difficulty regulating the use of steroids by these patients while receiving Vilo. This has all been taken into account and through FDA dialogue they are proceeding with a new improved protocol for FDA approval.
2) They discovered that Vilo dosing when doubled penetrated the tissues and not just the serum and resulted in little or no side effects. Consequently, it looks like they will be conducting the PG and HS and ANCA studies at double the dose of their competitor and this will give them a huge marketing and label advantage.
3) They think that they possibly have a more rapid onset of action and better tissue distribution than their competitor CCXI. Even though they are both c5a antagonists, Vilo may have different and better properties.
4) These studies take little time and the read outs will be just around the corner in the first quarter. The FDA is aboard and the CEO in his speech was excited about the cooperation and enthusiasm that the FDA has shown this time around.
5) Covid study is for an unmet need and it sounded like a total question mark as to whether or not it will show any effect, but the standard of proof has been drastically changed by their competitor's prior study design discussions with the FDA.
6) We have an incredible CEO. That was one of the best fireside chats that I have ever heard and he had a relaxed, confident and likeable tone throughout.
Raymond James doubles InflaRx price target to $20 ahead of COVID data 13:37 IFRX Raymond James analyst Steven Seedhouse raised the firm's price target on InflaRx to $20 from $10 and keeps an Outperform rating on the shares following the company's Q1 earnings report and ahead of its "highly anticipated" data from its Phase 2/3 trial of IFX-1 in COVID-19. Seedhouse has increased COVID-19 revenue contribution from IFX-1 in his model to about $70M at peak based on his "continually increasing conviction" that the 30-patient Part 1 cohort of the PANAMO trial in severe COVID patients will be positive, he tells investors.
This Phase II part of the trial was exploratory in nature and was not powered to show statistically significant differences in clinical endpoints. Relative change (%) from baseline to day 5 in the oxygenation index, chosen as the primary endpoint for the Phase II part, showed a large variability and dependency on patient positioning and intubation status which excludes this endpoint from being used in a confirmatory study.
InflaRx is now evaluating continuing the study in an adequately powered, placebo-controlled, double blinded, Phase III part using 28-day all-cause mortality as the primary endpoint, an accepted regulatory primary endpoint for critical care studies.
"Raymond James says market wrong on InflaRx COVID-19 data Raymond James analyst Steven Seedhouse thinks the market is wrong by penalizing InflaRx for uncertainties about mechanism, when a real mortality benefit is "apparent and plausible." The stock is trading down 27% to $5.28 after the company announced top-line results of the Phase 2 portion of a Phase 2/3 study of C5a antibody IFX-1 in severe COVID-19 patients. While the cohort missed the primary endpoint, there were positive trends in various measurements at day 28, including "most encouragingly" mortality, Seedhouse tells investors in a research note. The early data seem to suggest the "vasculopathy" phenotype in COVID may be improved via complement inhibition, which could be translating into a survival benefit, says the analyst. He believes asking InflaRx to hit the primary endpoint in the first Phase 2 cohort "for a new mechanism in such a mysterious illness is unreasonable." Mortality is what matters most and the trend for IFX-1 "looks great so far," says Seedhouse. The analyst keeps an Outperform rating on InflaRx with a $20 price target."
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